This study is being conducted to determine the safety, tolerability, pharmacokinetics, and effects of EVP-0962 on cerebral spinal fluid Amyloid concentrations in healthy subjects and in subjects with mild cognitive impairment or early Alzheimer's disease.
This is a randomized, double-blind, sequential escalating repeat daily dose study conducted in two parts. The first part is being conducted in healthy subjects and will evaluate safety, tolerability, and pharmacokinetics and pharmacodynamics of escalating EVP-0962 doses (10, 50 100 and 200 mg) or matching placebo following once-daily administration for 14 days. The second part will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of EVP-0962 following once-daily administration for 14 days in patients with mild cognitive impairment or early Alzheimer's disease at the dose level selected based on the available safety, pharmacokinetics and pharmacodynamics observations in the first part.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
Glendale Adventist Medical Center
Glendale, California, United States
The number of adverse experiences reported by subjects and/or observed by investigator and repeated clinical evaluations of physical examinations, vital signs, 12-lead ECG (electrocardiogram), and lab tests (hematology, chemistry, urinalysis)
Time frame: Screening (Day-45 to Day -1) through Day 23 (end of study visit)
To measure the rate of synthesis of Amyloid Beta in cerebral spinal fluid of healthy subjects
Time frame: 0-36 hours post dose
To measure the concentration of Amyloid Beta in cerebral spinal fluid
Time frame: 0-36 hours post dose
To measure the rate of synthesis of Amyloid Beta and steady-state levels in the cerebral spinal fluid in MCI or early Alzheimer's disease patients
Time frame: 0-36 hours post dose
To determine single-and repeat-dose EVP-0962 pharmacokinetics in cerebral spinal fluid and plasma
Time frame: 0-36 hours post dose
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